Amneal Pharmaceuticals of New York, LLC recalls Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewate…
- Recall date
- October 27, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0090-2024
- FDA classification
- Class II
- Brand / firm
- Amneal Pharmaceuticals of New York, LLC
- Sold / distributed
- Nationwide in the USA and Puerto Rico
Why it was recalled
Failed Dissolution Specifications
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10
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